Dupixent approved as first biologic for young children with uncontrolled chronic spontaneous urticaria

Regeneron and Sanofi have announced FDA approval of Dupixent (dupilumab) for children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine treatment. The approval expands on an existing indication covering adults and adolescents aged 12 and older.

CSU is a chronic skin disease causing unpredictable bouts of itch and hives that can be particularly debilitating for young children during their most formative years. Until now, young patients had limited treatment options that did not address the underlying drivers of the disease.

The approval is based primarily on data from the LIBERTY-CUPID clinical trial program, drawing on efficacy and safety data from two Phase 3 trials in adults and adolescents, complemented by pharmacokinetics data from the CUPIDKids trial in children aged 2 to 11. In the adult and adolescent trials, Dupixent significantly reduced itch severity and urticaria activity compared to placebo at week 24, and increased the likelihood of well-controlled disease or complete response. The safety profile in younger children was consistent with that seen across Dupixent’s approved dermatological indications, with no new adverse reactions identified.

George Yancopoulos, Regeneron’s Chief Scientific Officer and a principal inventor of Dupixent, highlighted the broader significance of the approval: “Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children. As the most widely used innovative branded antibody medicine, Dupixent has the potential to change yet another treatment paradigm.”

Alyssa Johnsen, Global Therapeutic Area Head for Immunology Development at Sanofi, pointed to the unmet need the approval addresses: “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of chronic spontaneous urticaria. Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease.”

This marks the fifth disease driven in part by type 2 inflammation for which Dupixent is approved in children younger than 12.

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Related Topics and Keywords

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